The Opportunity:

We are seeking a highly qualified and experienced EU-dQPPV to join our dynamic team and will report to the QPPV. The Deputy EU Qualified Person for Pharmacovigilance (Deputy EU QPPV) serves as the designated deputy to the EU QPPV and supports the oversight, maintenance, and continuous improvement of the company's European pharmacovigilance (PV) system. The role ensures compliance with European Union pharmacovigilance legislation, Good Pharmacovigilance Practices (GVP), and applicable local requirements.

The Associate Director, Deputy QPPV supports the QPPV in maintaining, executing, and continuously improving a fully compliant global Pharmacovigilance system. In the absence of the QPPV, this individual assumes full legal and functional responsibility for the safety of all marketed products and products under clinical development.

Key Responsibilities

Pharmacovigilance System Oversight

• PSMF Management: Support the EU QPPV in maintaining and overseeing the Pharmacovigilance System Master File (PSMF).

• Compliance Monitoring: Track key performance indicators (KPIs) and compliance metrics for case processing, aggregate reporting, and signal detection.

• SDEA Oversight: Review and approve Safety Data Exchange Agreements (SDEAs) with commercial partners and local affiliates.

Deputy EU QPPV Responsibilities

• Full Deputization: Act as the delegated EU QPPV during periods of absence, ensuring uninterrupted oversight of the EU PV system.

• Maintain continuous awareness of emerging safety issues, regulatory inspections, audits, and compliance obligations.

• Support interactions with European Medicines Agency (EMA), national competent authorities, and other regulatory agencies.

• Ensure adequate arrangements exist for 24/7 availability of the EU QPPV function.

Safety Surveillance and Risk Management

• Contribute to signal detection, signal management, safety evaluation, and benefit-risk assessment activities.

• Review and provide strategic input into Risk Management Plans (RMPs), signal assessments, and safety governance discussions.

• Support oversight of aggregate safety reports including PSURs/PBRERs and Development Safety Update Reports (DSURs), as applicable.

Compliance and Inspection Readiness

• Support preparation and management of regulatory inspections and internal/external audits.

• Track and oversee implementation of corrective and preventive actions (CAPAs).

• Monitor key PV compliance metrics and ensure timely escalation of compliance risks.

Vendor and Partner Oversight

• Contribute to Safety Data Exchange Agreements (SDEAs) and pharmacovigilance contractual requirements.

• Ensure responsibilities and compliance expectations are clearly defined and monitored.

Local Affiliate & Partner Governance

• Affiliate Alignment: Ensure local PV contacts (LCPs) and affiliates adhere to global data collection timelines and reconciliation standards.

• Training Delivery: Support and provide GVP and safety awareness training across the organization and to external vendors.

Knowledge and Skills

• Extensive knowledge of EU pharmacovigilance legislation and GVP Modules.

• Strong understanding of signal management, risk management, aggregate reporting, and safety governance.

• Familiarity with PV systems, databases, and PSMF management.

• Excellent communication and stakeholder management skills.

• Strong analytical, leadership, and problem-solving capabilities.

• Ability to work effectively in a fast-paced biotechnology environment.

Required Skills, Experience and Education:

• Advanced degree in life sciences (MD, PharmD, PhD, or MSc in a relevant scientific discipline).

• 7–9+ years of experience in international pharmacovigilance, with a strong focus on PV quality, compliance, or QPPV office operations.

• Experience managing global PV systems and interacting with health authorities.

• Fluent in written and spoken English, fluency in a second European language an advantage.

• In-depth knowledge of GVP, EU PV legislation and global regulatory frameworks.

Preferred Skills:

• Familiarity with PV systems, databases, and PSMF management.

• Excellent communication and stakeholder management skills.

• Strong analytical and problem-solving capabilities.

• Ability to work effectively in a fast-paced biotechnology environment.

Travel Requirements

• Occasional travel within Europe and internationally for inspections, audits, health authority meetings, and company meetings (approximately 10–20%).

Location & registration: The dQPPV must be located within the EU/EEA.

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